MYOMEGA  OMEGA 3PLUS PAIN RELIEF RUB- menthol and camphor (synthetic) cream 
Concept Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MYOMEGA
OMEGA™
3+
Triple Strength
Pain
Relief
Rub

Drug Facts

Active ingredient Purpose
Menthol 12% Pain Relieving
Camphor 6% Pain Relieving

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, sprains

Warnings

For external use only.

do not apply to wounds or damaged skin, do not bandage tightly

When using this product do not get into eyes avoid contact with other mucous membranes

Flammable: Keep from heat and flame.

Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control center right away , if pregnant or nursing, seek the advice of a health professional before using

Directions

Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock

Children under 12 years of age consult a physician

Apply liberally to affected area not more than 3 to 4 times daily

Gently massage into the skin until fully absorbed

Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

Inactive ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Copolymer, Corn Starch Modified, Linum Usitatissmum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Methane Carboximide, Methyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octenylsuccinate, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate.

Questions or comments?

Call 1-888-373-8831 or visit us at www.myomegapain.com

Concept Laboratories, Inc.
Chicago, IL 60642 (USA)
#CL9913R1

PRINCIPAL DISPLAY PANEL - 106 g Bottle Label

MyOmega

Paraben-free topical analgesic for:
Strains • Sprains • Muscle Pain • Tension

Omega
3+

Triple Strength
Pain
Relief
Rub

with:

IcePearls

Net Wt 3.75 oz (106 g)

Principal Display Panel - 106 g Bottle Label
MYOMEGA   OMEGA 3PLUS PAIN RELIEF RUB
menthol and camphor (synthetic) cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-141
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 12.72 g  in 106 g
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic) 6.3 g  in 106 g
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
LAURYL LAURATE (UNII: GPW77G0937)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ALCOHOL (UNII: 3K9958V90M)  
LINSEED OIL (UNII: 84XB4DV00W)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
ACAI OIL (UNII: Z0W6766A2W)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64058-141-64 106 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part348 08/17/2011
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
Name Address ID/FEI Business Operations
Concept Laboratories, Inc. 962282612 MANUFACTURE

Revised: 9/2011
Document Id: 0622f620-3b35-4679-b5f2-ff23b1693340
Set id: 489474b5-6190-42f8-b2fd-32829f756576
Version: 1
Effective Time: 20110909
 
Concept Laboratories, Inc.